The National Institute
for Occupational Safety and Health (NIOSH) announces the availability of
funds for fiscal year (FY) 2011 to support one cooperative agreement (U24)
for continuation of the National Mesothelioma Virtual Bank for
Translational Research.

Key Dates

Publication Date

December 23, 2010

Letter of Intent Due Date

February 15, 2011

Application Due Date

Received
by March 15, 2011

Scientific Merit Review

April 2011

Secondary Review

May 2011

Start Date

September 1, 2011

Expiration Date

March 16, 2011

Due Dates for E.O. 12372

Executive Order 12372 does not apply to this program.

NOTE: The policies,
guidelines, terms, and conditions of the HHS Centers for Disease Control and
Prevention (CDC) stated in this funding opportunity announcement (FOA) might
differ from those used by the HHS National Institutes of Health (NIH). If
written guidance for completing this application is not available on the CDC
website, then CDC will direct applicants elsewhere for that information.

It is critical that applicants follow the instructions in
the PHS 398
Grant Application Guide except where instructed to do otherwise (in this
FOA or in a Notice from the NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the FOA) is
required and strictly enforced. Applicants must read and follow all application
instructions in the Application Guide as well as any program-specific
instructions noted in Section IV. When
the program-specific instructions deviate from those in the Application Guide,
follow the program-specific instructions. Paper applications must be
submitted using PHS 398 Forms.

Note: The Research Strategy component of the Research Plan is limited to 15 pages.

Applications
that do not comply with these instructions may be delayed or not accepted for
review.

The goal of the NIOSH research program is to develop an
understanding of the risks and conditions that are associated with occupational
diseases and injuries, to explore methods for reducing risks and for preventing
or minimizing exposure to hazardous conditions in the workplace, and to
translate significant scientific findings into prevention practices and
products that will effectively reduce work-related illnesses and injuries.
Specific research priorities are derived from the National Occupational
Research Agenda (NORA), which is used by NIOSH for determining how best to
carry out its mission of providing national and world leadership guidance in
preventing work-related illnesses and injuries. Detailed information about NORA
can be found at http://www.cdc.gov/niosh/nora/. One
NORA Cross-Sector Program, Cancer, Reproductive and Cardiovascular
Disease, is particularly relevant to this RFA.

Malignant mesothelioma
is a rare form of cancer that presents as a malignant growth in the sac lining
(mesothelium) of the chest (the pleura), or the abdominal cavity (the peritoneum)
or the lining around the heart (the pericardium). Asbestos exposure through
inhalation of asbestos fibers is the main cause of mesothelioma. Because asbestos
mineral fibers are flame and heat resistant, pliable, strong, refractory to
corrosive chemicals, and provide insulation, asbestos has been used to
insulate buildings from heat and protect against fire (it has been especially
important in the shipbuilding industry), in fabric to make protective suits, as
a brake liner (e.g. in automobiles and railroad rolling stock) and for engine
gaskets, and in making filters (e.g. in the chemical industry). Thus, Americans have been exposed to asbestos in the workplace since its use became
wide-spread in the mid- to late-nineteenth century.

Although the use of asbestos has been significantly
reduced since the 1970s, mesothelioma is still a significant occupational
health burden. Each year, in the United States, approximately 2,500 people are
diagnosed with mesothelioma (~20% female and ~4% Black). This is because the
latency period for mesothelioma is 20-50 years, with the average patient age of
70 years at the time of diagnosis. Furthermore, the risk of asbestos exposure
continues today in many occupational settings, and in buildings such as homes,
offices and schools, in which asbestos was previously used or installed and
remains present. The incidence of mesothelioma continues to rise in the U.S.
and worldwide. The peak incidence worldwide is expected in 2020, and in the
U.S. it is predicted that there will be approximately 71,000 new cases between
2003 and 2054. Early diagnosis is critical if treatment is to be effective and
markers for early detection are needed. In addition, treatment modalities
remain difficult.

The purpose of the virtual mesothelioma registry and
tissue bank is to provide a resource for investigators engaged in the research
of mesothelioma. It is intended to provide biospecimens (blood, plasma, white
blood cells, and normal and mesothelioma tissues) together with demographic
data (age, sex, race, occupational history and other epidemiologic
information), and clinical data (stage, treatment and survival information).
Additionally, the virtual registry and tissue bank could also serve as a
repository and offer a library of reagents and data (e.g.,antibodies, genomic,
transcriptomic and proteomic data) for sharing among investigators.

The goal is to provide a resource that will assist in
development of early markers of disease, biomarkers of stage and prognosis, as
well as improved treatment modalities. Specifically, it will provide access to
biospecimens for research on biomarkers for early detection (e.g., tissues,
plasma proteins), susceptibility (e.g., DNA or white blood cells),
epidemiologic research (e.g., occupational history and death certificate
information), and clinical research (improved prognosis through improvements in
treatment). Through this RFA, the awardee will maintain and expand the current National
Mesothelioma Virtual Bank for Translational Research, improving its capability to serve as a resource for biomedical research
and the clinical science community.

A virtual registry and tissue bank is one in which participating
institutions will make available their independent stores of mesothelioma
tissue for public access and use through a centralized internet-based database
or registry. This registry is used for data recording and collection related to
each tissue sample. Each participating institution is responsible for the data
entry and updates into the registry for each of their samples. The recipient of
this cooperative agreement will manage, and further enhance the
development and utility of the NMVB for Translational Research.

Research
Objectives

The
objectives of this research are to:

Maintain and expand
the NMVB
for Translational Research. By seeking new collaborations
with other institutions and organizations, the recipient will enroll increasing
numbers of mesothelioma patients to become participants in the registry and
tissue bank. Participating institutions will identify and enroll mesothelioma
patients. They will expand the collection of patients’ clinical and demographic
data (retrospective and prospective), including data determined to be necessary
for diagnosis and inclusion in the registry and tissue bank; and biological
samples including (but not limited to) biopsy material (fixed or frozen), serum
white blood cells and nucleic acids. The recipient will continue to establish
and improve standards for participants to post clinical data, demographic data,
and available samples in a distributed network allowing databases of individual
participating institutions to be accessed together, forming a single virtual
database.

Promote
the mesothelioma patient registry and tissue bank as a resource for the
clinical science community. The recipient will, together with participating
institutions, continue to establish and maintain a process for qualified
applicants to access information in the database and to request available
samples for use in legitimate research. Together with NIOSH, the recipient
will continue to expand and improve the marketing of the availability and
utility of the mesothelioma virtual registry and tissue bank as a resource to
prospective users, including the research community and public using
information obtained by this tracking documentation. The recipient will work
with existing mesothelioma tissue and data banks, and develop innovative plans
to promote the benefits and uniqueness of the virtual registry and bank.

Document the usefulness of the
mesothelioma virtual registry and tissue bank to the scientific community in
the conduct of studies that address the etiology, mechanisms, diagnosis and
treatment of malignant mesothelioma. The recipient will maintain and improve a
record of requests for access to the database; requests for use of tissue
samples; tissue samples distributed; scientific abstracts, presentations, and
publications resulting from use of the registry and tissue bank; and patents or
products resulting from use of the registry and tissue bank.

Section II. Award Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there
will be substantial Federal scientific or programmatic involvement.
Substantial involvement means that, after award, scientific or program staff
will assist, guide, coordinate, or participate in project activities.

NIOSH anticipates that $1,028,000 will be available in FY
2011, and that one award will be made under this FOA. Awards issued under
this FOA are contingent on the availability of funds and submission of a
sufficient number of meritorious applications.

Ceiling and Floor of Individual Award Range

Ceiling level of funding for the program: $1,028,000 total
costs (including direct and indirect costs) per year, for up to 5 years.

Floor level of funding for the program: None

Project Period Length

The maximum project period is 5 years. Throughout the
project period, NIOSH’s commitment to continuation of awards will be
contingent on available funds, evidence of satisfactory progress by the
recipient (as documented in required reports), and the determination that
continued funding is in the best interest of the Federal government.

HHS/CDC grants policies
as described in the HHS Grants Policy
Statement will apply to the applications
submitted and awards made in response to this FOA.

Section
III. Eligibility Information

1. Eligible Applicants

Applicant
institutions must have an established registry and tissue bank with capability
for functioning as a national virtual registry and tissue bank, one in which participating institutions
will make available their independent stores of mesothelioma tissue for public
access and use through a centralized internet-based database or registry. This virtual registry
and tissue bank must be able to provide a resource for investigators engaged in
the research of mesothelioma, to include biospecimens (blood, plasma, white
blood cells, and normal and mesothelioma tissues) together with demographic
data (age, sex, race, occupational history and other epidemiologic
information), and clinical data (stage, treatment and survival information).

Eligible Organizations

Higher Education Institutions:

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for CDC support as Public or Private
Institutions of Higher Education:

A Bona Fide Agent is an agency/organization identified by
the state as eligible to submit an application under the state eligibility in
lieu of a state application. If applying as a bona fide agent of a state or
local government, a legal, binding agreement from the state or local government
as documentation of the status is required.

Non-domestic (non-U.S.) Entities (Foreign Organizations) are
not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are
not allowed.

Required Registrations

Applicant organizations must complete the following registrations
as described in the PHS 398 Grant
Application Guide to be eligible to apply for or receive an award. Applicants
must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number
in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD/PIs) must
also work with their institutional officials to register with the eRA Commons
or ensure their existing eRA Commons account is affiliated with the eRA Commons
account of the applicant organization.

All registrations must be successfully completed and active before the
application due date. Applicant organizations are strongly encouraged to start
the registration process at least four (4) weeks prior to the application due
date.

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Project Director/Principal
Investigator (PD/PI) is invited to work with his/her organization to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for HHS/CDC support.

Only one application per institution (normally identified by
having a unique DUNS number) is allowed.

HHS/CDC will not accept any application in response to this
FOA that is essentially the same as one currently pending initial peer review
unless the applicant withdraws the pending application. HHS/CDC will not accept
any application that is essentially the same as one already reviewed.

Applicants must follow the instructions in the PHS 398 Grant
Application Guide, except where instructed in this funding opportunity
announcement to do otherwise. Conformance to the requirements in the
Application Guide is required and strictly enforced. Applications that are out
of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows NIOSH staff to estimate the potential review workload
and plan the review.

By the date listed in Part 1.
Overview Information, prospective applicants are asked to submit a letter
of intent that includes the following information:

Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

Individuals are required to comply with the instructions
for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and
Genome Wide Association Studies (GWAS) as provided in the PHS398 Application
Guide.

Appendix

Appendices are optional. NIOSH, AHRQ and
NIH issued a notice on 15 April 2010 about limits on
appendix materials that may be submitted with grant applications. Appendix
materials must be well organized, clearly labeled as to the relevant section of
the application, and ordered similarly to the application contents.

Do not use the appendix to
circumvent page limits. Follow all instructions for the Appendix (please note
all format requirements) as described in the PHS 398 Application Guide, with
the following modifications:

·
An application that does not observe the required page limits may
not be considered in the review process.

All paper PHS 398 applications submitted must provide appendix
material on CDs only. Include five identical CDs in the same package with the
two application copies to the NIOSH Scientific Review Officer listed above.

Applications exceeding page limits or requests for greater
than $1,028,000 total costs (including direct and indirect costs) per year, for
up to 5 years, will be considered nonresponsive and will not be reviewed.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review and for responsiveness by
CDC/NIOSH. Applications that are incomplete and/or nonresponsive will not be
reviewed.

Section V. Application Review
Information

1. Criteria

All applications submitted to CDC/NIOSH in support of public
health research are evaluated for scientific and technical merit through the CDC
peer review system. Applications should be relevant to the NIOSH mission and specifically to
mesothelioma research. Only the review criteria described below will be
considered in the review process.

Overall Impact

Reviewers will provide an overall impact/priority score to
reflect their assessment of the likelihood for the project to exert a
sustained, powerful influence on the research field(s) involved, in
consideration of the following review criteria and additional review criteria
(as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Significance

Does the project address an important problem or a
critical barrier to progress in the field? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field? Does the proposed research further develop
the concept and usefulness of a virtual registry and tissue bank? Will the
proposed research further enhance access of the clinical science community to
mesothelioma tissue and data resources?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers
well suited to the project? Have they demonstrated an ongoing record of
accomplishments that have advanced their field(s)? If the project is
collaborative or multi-PD/PI, do the investigators have complementary and
integrated expertise; are their leadership approach, governance and
organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed? Does the PI describe
how the enhanced NMVB for Translational Research will serve as a unique
resource for researchers in this field and how the research team will
collaborate with other related resources to further enhance the utility of the
virtual registry and tissue bank?

Approach

Are
the overall strategy, methodology, and analyses well-reasoned and appropriate
to accomplish the specific aims of the project? Are potential problems,
alternative strategies, and benchmarks for success presented? If the project is
in the early stages of development, will the strategy establish feasibility and
will particularly risky aspects be managed?

If the project involves clinical
research, are the plans for 1) protection of human subjects from research
risks, and 2) inclusion of minorities and members of both sexes/genders, as
well as the inclusion of children, justified in terms of the scientific goals
and research strategy proposed?

Is the project fully described
and does it include a plan for dissemination of results? Does the project have
a well-developed and conceived evaluation plan?

Environment

Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements? Does the applicant provide evidence of existing systems and/or
infrastructure that are critical to the success of the proposal? Does the
applicant have an existing NMVB for Translational Research or other actual or
virtual registry and tissue bank? Has the applicant addressed how it will work
with the existing registry and bank to maintain, enhance and improve the bank
through this new cooperative agreement?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact/priority score, but will
not give separate scores for these items.

Confidentiality

Because of the sensitive nature
of an internet-based registry, applicants need to specifically address how
confidentiality issues will be handled in the reporting and use of data from
the internet-based registry. Does the applicant describe the type of
information that will be collected related to the tissues and other
biospecimens included in the virtual registry and bank, and how this
information will be used and protected?

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the HHS/CDC Requirements under AR-1 Human
Subjects Requirements.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research,
the committee will evaluate the proposed plans for inclusion of minorities and
members of both genders, as well as the inclusion of children. For additional
information on review of the Inclusion section, please refer to the Inclusion of Women and
Racial and Ethnic Minorities in Research.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Renewals

For Renewals (formerly called competing continuation
applications), the committee will consider the progress made in the last
funding period.

Resubmissions

Not applicable.

Revisions

Not applicable.

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact/priority score.

Resource Sharing Plans

HHS/CDC policy requires that recipients of grant
awards make unique research resources and data readily available for research
purposes to qualified individuals within the scientific community after publication.
Please see: http://www.cdc.gov/od/foia/policies/sharing.htm.
Investigators responding to this funding opportunity should include a plan on
sharing research resources and data.

Budget and Period of Support

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

Applications will be assigned to NIOSH and will compete for
available funds with all other recommended applications submitted in response
to this FOA. Following initial peer review, recommended applications will
receive a second level of review. The following will be considered in making
funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, HHS/CDC
will request "just-in-time" information from the applicant as
described in the HHS Grants
Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by the
grants management officer is the authorizing document and will be sent via
email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. Pre-award
costs are not allowed.

All HHS/CDC grant and cooperative agreement awards include
the HHS Grants Policy Statement as part of the NoA. For these terms of award,
see the HHS
Grants Policy Statement Part II: Terms and Conditions of Award, Overview of
Terms and Conditions of Award and Requirements for Specific Types of Grants. Additional
requirements are available at the following internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm.

2.A Cooperative
Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and
not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB)
administrative guidelines, U.S. Department of Health and Human Services (DHHS)
grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is
applicable when State and local Governments are eligible to apply), and other
HHS, PHS, and CDC grant administration policies.

The administrative and funding instrument used for this program will be the
cooperative agreement, an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial CDC programmatic
involvement with the awardees is anticipated during the performance of the
activities. Under the cooperative agreement, the HHS/CDC purpose is to support
and stimulate the recipients' activities by involvement in and otherwise
working jointly with the award recipients in a partnership role; it is not to
assume direction, prime responsibility, or a dominant role in the activities.
Consistent with this concept, the dominant role and prime responsibility
resides with the awardees for the project as a whole, although specific tasks
and activities may be shared among the awardees and HHS/CDC as defined below. The
grantee is strongly encouraged to review the HHS grant policy statement, for
aid with post award administration, at http://www.hhs.gov/grantsnet/adminis/gpd/index.htm.

Facilitate goals and agenda for Coordinating/Steering Committee
meetings, as appropriate.

NIOSH Project Scientist

NIOSH anticipates having
substantial scientific involvement during the conduct of this activity in the
form of technical assistance, collaboration, guidance and coordination. A NIOSH
Project Scientist may be involved and, if so, will have responsibilities that include
the following:

The
NIOSH Project Scientist/Collaborator will be named in the award
notice and will work closely with the NIOSH PO. Should more than one NIOSH
Project Scientist be involved, there will be only one NIOSH vote reached by
consensus.

2.A.3
Areas of Joint Responsibility

Coordinating/Steering Committee

The awardee will manage the NMVB for Translational Research
with collaboration, consultation and guidance from CDC/NIOSH. A Coordinating/Steering
Committee will be established by the recipient and will consist of: 1) the Principal
Investigators 2) two other representatives from the awardee institution; 3) two
members from each tissue/data accruing site; 4) a patient advocate; 5) the
NIOSH Program Official; and 6) the NIOSH Project Scientist. Additional members
may be added by majority approval.

The Coordinating/Steering Committee will help guide
activities undertaken by the NMVB for Translational Research. This will include
a) proper operating policies, b) a Manual of Standard Operations for procedures
to access, process and distribute tissue; c) uniform quality control methods,
e) rules for access to the clinical and outcome data associated with the
accrued cases; and f) ensuring that adequate security and confidentiality are
maintained.

An annual Face-to-Face meeting of the Coordinating/Steering
Committee will be held to discuss progress, important findings, and challenges.
These meetings will also provide an opportunity for critical discussions on
enhancing partnerships, new collaborations and future directions.

Dispute Resolution Process

Any
disagreements that may arise in scientific or programmatic matters (within the
scope of the award) between award recipients and the NIOSH may be brought to
Dispute Resolution. A Dispute Resolution Panel composed of three members will
be convened. It will have three members: a designee of the Steering Committee
chosen without NIOSH staff voting, one NIOSH designee, and a third designee
with expertise in the relevant area who is chosen by the other two; in the case
of individual disagreement, the first member may be chosen by the individual
awardee. This special dispute resolution procedure does not alter the awardee's
right to appeal an adverse action that is otherwise appealable in accordance
with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part
16.

An annual report suitable for public distribution will be
provided to the NIOSH PO at the end of each calendar year.

A final progress report, invention
statement, and Financial Status Report are required when an award is
relinquished when a recipient changes institutions or when an award is
terminated, no more than 90 days after the end of the project period.

The Federal Funding
Accountability and Transparency Act of 2006 (Transparency Act), includes a
requirement for awardees of Federal grants to report information about
first-tier subawards and executive compensation under Federal assistance awards
issued in FY2011 or later. All awardees of applicable NIH grants and
cooperative agreements are required to report to the Federal Subaward
Reporting System (FSRS) available at www.FSRS.gov on all subawards over $25,000. See the NIH Grants Policy Statement
for additional information on this reporting requirement.

Section VII.
Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.